Hospital Universitario Virgen del Rocío, Instituto de Biomedicina (IBIS), Sevilla, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain.
Hospital de Araba, Vitoria-Gasteiz, Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain.
Thromb Res. 2023 Aug;228:1-9. doi: 10.1016/j.thromres.2023.05.005. Epub 2023 May 19.
Chronic thromboembolic pulmonary hypertension (CTEPH) is a long-term sequel to pulmonary embolism (PE) whose incidence varies according to different published studies. We have carried out this study to determine its incidence within 2 years after index pulmonary embolism and to study limitations to an early diagnosis.
OSIRIS is a multicentre, longitudinal cohort study. Patients were followed for 3, 6, 12, and 24 months after pulmonary embolism using a structured three-step algorithm. A physician-centered questionnaire at least one positive response in a screening proceeded to the second step, transthoracic echocardiography. The third step consisted of ventilation/perfusion lung scintigraphy and right heart catheterisation. A transthoracic echocardiography was performed in patients without positive response in the screening questionnaire after 2 years. CTEPH diagnosis required haemodynamic confirmation by right heart catheterisation and mismatched perfusion defects on lung scintigraphy.
A total of 1191 patients were enrolled in 18 Spanish hospitals. Cumulative CTEPH incidence after 2-years PE was: 2.49 % (95 % CI: 1.68-3.56) and the incidence rate of CTEPH was 1.1 cases per 1000 person-months (95 % CI: 0.725; 1.60). The CTEPH algorithm presented a lack of adherence of 29 %; patient and physician preferences posed barriers to the triage algorithm The screening questionnaire, in patients who completed the follow-up, shows a specificity of 91.3 % (89.0-93.2 %) and negative predictive value of 99.4 % (98.4-99.8 %)..
OSIRIS provides practiced clinical based data on the chronic thromboembolic pulmonary hypertension incidence and identified barriers to the implementation of a 3-step triage algorithm for its detection.
clinicaltrials.gov identifier: NCT03134898.
慢性血栓栓塞性肺动脉高压(CTEPH)是肺栓塞(PE)的长期后遗症,其发病率因不同的已发表研究而有所不同。我们进行了这项研究,以确定其在肺栓塞后 2 年内的发病率,并研究早期诊断的局限性。
OSIRIS 是一项多中心、纵向队列研究。通过结构化的三步算法,在肺栓塞后 3、6、12 和 24 个月对患者进行随访。在筛选过程中,医生会进行一项以问卷为基础的检查,只要有一个阳性反应,就会进入第二步,即经胸超声心动图检查。第三步包括通气/灌注肺闪烁扫描和右心导管检查。如果在筛选问卷后 2 年内患者无阳性反应,则进行经胸超声心动图检查。CTEPH 的诊断需要通过右心导管检查和肺闪烁扫描上不匹配的灌注缺损来确认血流动力学异常。
共有 1191 名患者在 18 家西班牙医院参与了这项研究。PE 后 2 年的累积 CTEPH 发病率为:2.49%(95%可信区间:1.68-3.56),CTEPH 的发病率为每 1000 人月 1.1 例(95%可信区间:0.725;1.60)。CTEPH 算法的依从性差,为 29%;患者和医生的偏好是分诊算法的障碍。在完成随访的患者中,筛选问卷的特异性为 91.3%(89.0-93.2%),阴性预测值为 99.4%(98.4-99.8%)。
OSIRIS 提供了关于慢性血栓栓塞性肺动脉高压发病率的基于临床实践的数据,并确定了实施三步分诊算法以检测该病的障碍。
clinicaltrials.gov 标识符:NCT03134898。